美国最高法院裁定人类基因不可获得专利

美国最高法院于6月13日裁定，私营企业无权获取人类基因的专利。

最高法院认为，自然形成的DNA片段是“天然产物”，不符合申请专利的条件。但最高法院也裁定，人工合成的DNA——即互补DNA(cDNA)可以获取专利。

最高法院考虑了Myriad基因公司对BRCA1和BRCA2基因的专利的正当性。这2种基因与乳腺癌与卵巢癌风险增高有关。

Myriad基因公司的科学家在20世纪90年代中期发现了BRCA1和BRCA2基因的位置和序列，自那以后，他们便掌握了这2种基因突变的诊断性检查的专有权。但批评者认为Myriad基因公司对检查的垄断损害了患者的权益，因为这种检查价格高昂，而且没有替代性的确诊检查可供选择。

Clarence Thomas法官在法庭意见书中写道：“无可争辩的是，Myriad基因公司并未创造或改变BRCA1和BRCA2基因中的任何遗传信息编码。该公司的主要贡献在于发现了这2种基因在第13号和17号染色体上的准确位置和遗传序列。”

多位法官总结认为，单凭确定基因及其周围遗传物质编码的信息并不足以获得专利。不过，cDNA并不是自然形成的，因此采用这一技术的检查可以获得专利。

已入禀一份非当事人意见陈述以支持将Myriad基因公司专利无效化的美国医学会(AMA)对最高法院的本次判决表示赞许。

AMA主席Jeremy A. Lazarus博士在声明中指出：“移除生命模块的专利可确保以理解人类DNA为基础的科学探索和医学治疗仍能自由进行和广泛散播，而不是被藏在由专有权构成的灌木丛之中。”

加入了针对Myriad基因公司的诉讼的美国民权同盟(ACLU)表示，这一判决推倒了患者治疗与医疗创新的一大障碍。ACLU女权项目高级律师Sandra Park在声明中指出：“患者将能够更容易地获得遗传学检查，科学家将能够研究这些基因而不必担心惹上官司。”

最高法院的裁定来得太晚，已难以对BRCA1和BRCA2检查产生太大的实质影响，因为Myriad基因公司的20年独家专利到2015年就将到期。

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By: MARY ELLEN SCHNEIDER, Cardiology News Digital Network

Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.

In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.

In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.

Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.

"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."

The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.

The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.

“Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights,” Dr. Jeremy A. Lazarus, AMA president, said in a statement.

The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.

The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.